Cleared Special

K081391 - VIP ANTERIOR CERVICAL PLATE SYSTEM

K081391 is the FDA 510(k) clearance for VIP ANTERIOR CERVICAL PLATE SYSTEM by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 45-day FDA review.

K081391 · Globus Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
45d
Days
Class 2
Risk

K081391 is an FDA 510(k) clearance for the VIP ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on July 3, 2008 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K081391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date July 03, 2008
Days to Decision 45 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K081391.
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K082273 · Depuy Spine, Inc. · Sep 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · Medtronic Sofamor Danek · Aug 2008
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
K081418 · Spinal Elements, Inc. · Jul 2008
THOR ANTERIOR PLATING SYSTEM
K080773 · Stryker Spine · Jun 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · Medtronic Sofamor Danek USA, Inc. · Apr 2008
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM
K080191 · Depuy Spine, Inc. · Apr 2008